[Translation] This is a single-center, randomized, open-label, single (fasting/postprandial) oral bioequivalence study of dydrogesterone tablets conducted in healthy Chinese female subjects. The study involved two preparations, two sequences, four cycles, and a complete repeated crossover.
主要目的:观察中国健康女性受试者在空腹/餐后状态下单次口服受试制剂地屈孕酮片(规格:10 mg;生产企业:新疆新姿源生物制药有限责任公司)和参比制剂地屈孕酮片(商品名:达芙通®;规格:10 mg;持证商:Abbott B.V.;生产企业:Abbott Biologicals B.V.)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂地屈孕酮片和参比制剂地屈孕酮片(达芙通®)在中国健康女性受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Dydrogesterone Tablets (Specification: 10 mg; Manufacturer: Xinjiang Xinziyuan Biopharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (Trade name: Daphaston®; Specification: 10 mg; Licensee: Abbott B.V.; Manufacturer: Abbott Biologicals B.V.) in Chinese healthy female subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation Dydrogesterone Tablets and the reference preparation Dydrogesterone Tablets (Daphaston®) in Chinese healthy female subjects.